Anesthesia
Conditions
Keywords
lidocaine, jaw
Brief summary
Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal dosages, and a lower dosage of the buffered drug might be used with an effect equal to higher dosage not buffered. Clinical data are needed to confirm these anecdotal data. No published data exist comparing buffered local anesthetics at lower drug concentrations to current dosages commonly used in dental and oral surgical procedures
Detailed description
Specific Aims: Compare clinical depths of pulpal anesthesia for maxillary molar and canine teeth at 30min intervals post injection after maxillary field block anesthesia with buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine. Hypotheses: No differences exist in anesthetic depth for pulpal anesthesia after intraoral injection for maxillary field block anesthesia between buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine. Study Time Frame: 6 months: Month One Recruit 24 volunteers as subjects, Prepare case-books. Months Two-Three Clinical Study. Months Four-Five Analyze Lab data. Month Six Prepare Abstracts, Papers Methods: Blinded, Randomized Clinical Design, Recruit subjects with Institutional Review Board approved consent at University of North Carolina. Subjects will serve as their own controls in a cross-over AB/BA study design which is uniform within sequences, uniform within periods, and balanced. Randomized subjects to be injected orally for maxillary field block (Posterior alveolar, Anterior alveolar, Palatal sensory nerves) alternatively with 4cc of buffered 1% lidocaine with 1/100,000 epinephrine and 4cc non-buffered of 2% lidocaine with 1/100,000 epinephrine. Assessment: pre, and post-anesthetic administration for pulpal anesthesia with cold, electronic pulp test at maxillary molar and canine at 30 minute intervals.
Interventions
DRUGLidocaine
Intraoral maxillary field block
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* American Society of Anesthesiologists Risk Classification I Willingness to participate in two sessions
Exclusion criteria
* Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms teeth or oral mucosa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time to Pulpal Response After Maxillary Molar Anesthesia | Every 30 minutes up to 120 minutes Total | Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no. |
| Mean Time to Pulpal Response After Maxillary Canine Anesthesia | Every 30 minute up to 120 minutes total | Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants who were randomized to receive either Buffered 1% Lidocaine or Non-Buffered 2% Lidocaine | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 24 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 24 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
Mean Time to Pulpal Response After Maxillary Canine Anesthesia
Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no.
Time frame: Every 30 minute up to 120 minutes total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buffered 1% Lidocaine | Mean Time to Pulpal Response After Maxillary Canine Anesthesia | 77.1 minutes | Standard Deviation 30.8 |
| Non-Buffered 2% Lidocaine | Mean Time to Pulpal Response After Maxillary Canine Anesthesia | 70.9 minutes | Standard Deviation 35.3 |
Primary
Mean Time to Pulpal Response After Maxillary Molar Anesthesia
Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no.
Time frame: Every 30 minutes up to 120 minutes Total
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buffered 1% Lidocaine | Mean Time to Pulpal Response After Maxillary Molar Anesthesia | 98.8 minutes | Standard Deviation 30.6 |
| Non-Buffered 2% Lidocaine | Mean Time to Pulpal Response After Maxillary Molar Anesthesia | 84.5 minutes | Standard Deviation 27 |